AOSEPT (CLEAR CARE) PLUS Study

Not Applicable

Not yet recruiting

• Conditions: Contact Lens Care
• Interventions: Device: AOSEPT Plus and AOCup lens case; Device: AOSEPT Plus with HydraGlyde and AOCup lens case; Device: Habitual contact lenses

• Registration Number: NCT06588400
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.

Detailed Description

Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Study Start: 2025-10
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subject and parent/legally authorized representative able to understand and sign an Institution Review Board approved informed consent/assent form.
• Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
• Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

• Any ocular disease or condition that would contraindicate contact lens wear.
• Use of systemic or ocular medication that would contraindicate contact lens wear.
• Any known sensitivity to any ingredients in the study products.
• Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
• Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOSEPT Plus (CC)	AOSEPT Plus and AOCup lens case	AOSEPT Plus and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.
AOSEPT Plus (CC)	Habitual contact lenses	AOSEPT Plus and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.
AOSEPT Plus with HydraGlyde (CCP)	AOSEPT Plus with HydraGlyde and AOCup lens case	AOSEPT Plus with HydraGlyde and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.
AOSEPT Plus with HydraGlyde (CCP)	Habitual contact lenses	AOSEPT Plus with HydraGlyde and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.

Primary Outcome Measures

Name	Time	Method
Front surface deposits at Day 90	Day 90	Protein and lipid deposits on the front surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Back surface deposits at Day 90	Day 90	Protein and lipid deposits on the back surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Incidence of corneal infiltrative events	Up to Day 90	A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. Corneal infiltrative events will be detected by the investigator during an eye exam.
Incidence of microbial keratitis	Up to Day 90	Microbial keratitis is a sight-threatening infection of the cornea. Incidences of microbial keratitis will be detected by the investigator during an eye exam.
Incidence of solution induced corneal staining (SICS)	Up to Day 90	Corneal staining determined by the investigator to be solution-related will be graded by type (pattern of staining) and area (how much) in each of the 5 corneal regions: central, superior, nasal, inferior, temporal.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States